This is a first-in-human Phase I, multi-center, open-label study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS03 as monotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
96
ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).
Memorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGResearch Site
Fuzhou, Fujian, China
RECRUITINGResearch Site
Guangzhou, Guangdong, China
RECRUITINGIncidence of Adverse Events (AEs)
Number of patients with adverse events by system organ class and preferred term
Time frame: From the time of first dose to 28 days post last dose of ANS03
Incidence of Serious Adverse Events (SAEs)
Number of patients with serious adverse events by system organ class and preferred term
Time frame: From time of first dose to 28 days post last dose of ANS03
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Time frame: From time of first dose of ANS03 to end of DLT period (approximately 30 days)
Incidence of baseline laboratory finding, ECG and vital signs changes
measured by laboratory and vital sign variables over time including change from baseline
Time frame: From time of first dose to 28 days post last dose of ANS03
Proportion of patients with radiological response (ORR)
Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1
Time frame: From date of first dose of ANS03 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)
Objective Response Rate (ORR)
The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)
Time frame: From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
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Research Site
Shanghai, Shanghai Municipality, China
RECRUITINGResearch Site
Chengdu, Sichuan, China
RECRUITINGDuration of Response (DoR)
The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression
Time frame: From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Disease Control Rate (DCR)
The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)
Time frame: From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Progression free Survival (PFS)
The time from first dose until RECIST 1.1 defined disease progression or death due to any cause
Time frame: From date of first dose of ANS03 up until date of progression or death due to any cause (approximately 2 years)]
Overall Survival (OS)
The time from the date of the first dose of study treatment until death due to any cause
Time frame: From date of first dose of ANS03 up until the date of death due to any cause (approximately 2 years)
Pharmacokinetics of ANS03: Plasma PK concentrations
Measurement of plasma concentrations of ANS03, total antibody and total unconjugated warhead
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Area under the concentration time curve (AUC)
Measurement of PK parameters: Area under the concentration time curve (AUC)
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Maximum plasma concentration of the study drug (C-max)
Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Time to maximum plasma concentration of the study drug (T-max)
Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)
Time frame: Frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Clearance
Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Half-life
Measurement of PK parameters: Terminal elimination half-life (t 1/2)
Time frame: From date of first dose up until 28 days post last dose